N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders neurostimulator programmers

Fabricante

  • Dirección del fabricante
    Dr David Dunham Regulatory Affairs Manager – UK & IrelandMedtronic Limited Suite One Sherbourne House Croxley Business Centre Watford Herts WD18 8WWTel: 01923 212 213 Fax: 01923 241 004 E-mail: david.dunham@medtronic.com
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA